Rotational atherectomy systems and methods with shock absorbing element

ABSTRACT

A rotational atherectomy system may include a drive shaft, a motor, and a clutch with a threshold torque where the clutch may include a motor plate rotationally connected to the motor, a drive shaft plate rotationally connected to the drive shaft, and a biasing clutch configured to rotationally engage the motor plate and the drive shaft plate, wherein torques less than the threshold torque are transmitted completely between the motor plate and the drive shaft plate, which remain rotationally coupled by static friction, and wherein torques greater than the threshold torque cause the motor plate and the drive shaft plate to rotate relative to one another and cause a residual torque to be transmitted between the motor and the drive shaft, the residual torque being less than the threshold torque and being determined by a kinetic coefficient of friction.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/208,478 filed Mar. 13, 2014, which claims the benefit ofU.S. Provisional Patent Application 61/932,409 filed Jan. 28, 2014entitled devices, systems and methods for a shock absorbing drive systemfor medical devices and U.S. Provisional Patent Application 61/787,027entitled rotational atherectomy device with biasing clutch, filed Mar.15, 2013, the contents of which are hereby incorporated by referenceherein in their entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to devices and methods for removing tissue frombody passageways, such as removal of atherosclerotic plaque fromarteries, utilizing a rotational atherectomy device. In particular, theinvention relates to improvements in a rotational atherectomy devicehaving a biasing clutch and/or a shock absorbing element.

2. Description of the Related Art

Atherectomy is a non-surgical procedure to open blocked coronaryarteries or vein grafts by using a device on the end of a catheter tocut or shave away atherosclerotic plaque (a deposit of fat and othersubstances that accumulate in the lining of the artery wall). For thepurposes of this application, the term “abrading” is used to describethe grinding and/or scraping action of such an atherectomy head.

Atherectomy is performed to restore the flow of oxygen-rich blood to theheart, to relieve chest pain, and to prevent heart attacks. It may bedone on patients with chest pain who have not responded to other medicaltherapy and on certain of those who are candidates for balloonangioplasty (a surgical procedure in which a balloon catheter is used toflatten plaque against an artery wall) or coronary artery bypass graftsurgery. It is sometimes performed to remove plaque that has built upafter a coronary artery bypass graft surgery.

Atherectomy uses a rotating shaver or other device placed on the distalend of a catheter to slice away or destroy plaque. At the beginning ofthe procedure, medications to control blood pressure, dilate thecoronary arteries, and prevent blood clots are administered. The patientis awake but sedated. The catheter is inserted into an artery in thegroin, leg, or arm, and threaded through the blood vessels into theblocked coronary artery. The cutting head is positioned against theplaque and activated, and the plaque is ground up or suctioned out.

The types of atherectomy are rotational, directional, and transluminalextraction. Rotational atherectomy uses a high speed rotating shaver togrind up plaque. Directional atherectomy was the first type approved,but is no longer commonly used; it scrapes plaque into an opening in oneside of the catheter. Transluminal extraction coronary atherectomy usesa device that cuts plaque off vessel walls and vacuums it into a bottle.It is used to clear bypass grafts.

Performed in a cardiac catheterization lab, atherectomy is also calledremoval of plaque from the coronary arteries. It can be used instead of,or along with, balloon angioplasty.

Several devices have been disclosed that perform rotational atherectomy.For instance, U.S. Pat. No. 5,360,432, issued on Nov. 1, 1994 to LeonidShturman, and titled “Abrasive drive shaft device for directionalrotational atherectomy” discloses an abrasive drive shaft atherectomydevice for removing stenotic tissue from an artery, and is incorporatedby reference herein in its entirety. The device includes a rotationalatherectomy apparatus having a flexible, elongated drive shaft having acentral lumen and a segment, near its distal end, coated with anabrasive material to define an abrasive segment. At sufficiently highrotational speeds, the abrasive segment expands radially, and can sweepout an abrading diameter that is larger than its rest diameter. In thismanner, the atherectomy device may remove a blockage that is larger thanthe catheter itself. Use of an expandable head is an improvement overatherectomy devices that use non-expandable heads; such non-expandabledevices typically require removal of particular blockages in stages,with each stage using a differently-sized head.

U.S. Pat. No. 5,314,438 (Shturman) shows another atherectomy devicehaving a rotatable drive shaft with a section of the drive shaft havingan enlarged diameter, at least a segment of this enlarged diametersection being covered with an abrasive material to define an abrasivesegment of the drive shaft. When rotated at high speeds, the abrasivesegment is capable of removing stenotic tissue from an artery.

A typical atherectomy device includes a single-use disposable portion,which can be attached and detached from a non-disposable control unit(also referred to as a controller). The disposable portion includeselements that are exposed to saline and to the bodily fluids of thepatient, such as a handle, a catheter, a rotatable drive shaft, and anabrasive head. The handle includes a turbine that rotates the driveshaft, and a knob that can longitudinally advance and retract the driveshaft along the catheter. Often, the device has a foot switch thatactivates the handle.

Typical known atherectomy devices use pneumatic power to drive the driveshaft, with the controller managing the amount of compressed air that isdelivered to the turbine in the handle. The compressed air spins theturbine that, in turn, spins the drive shaft, and spins an abrasivecrown attached to the drive shaft. Orbiting motion of the crown enlargesand widens the channel opening of a restricted or blocked vascularvessel.

There is currently a great deal of effort devoted to incorporating othertypes of rotational actuators into the atherectomy devices, primarily toreplace the need for a source of compressed air. A motor requires a waylimit the torque delivered to the drive shaft. For instance, if thedistal end of the drive shaft encounters an obstacle and gets stuck(i.e., stops rotating), it is preferable that the torque delivered tothe drive shaft be limited, so that the drive shaft does not wind upexcessively and abruptly release. Such a sudden release of energy mayresult in damage to the patient or the device, and should be avoided.

Accordingly, there exists a need for a clutch between the motor and thedrive shaft in a rotational atherectomy device.

BRIEF SUMMARY OF THE INVENTION

In some embodiments, a rotational atherectomy system may include anelongated, rotatable, flexible drive shaft having a distal end forinsertion into a vasculature of a patient. The drive shaft may include aproximal end opposite the distal end that remains outside thevasculature of the patient. The system may include a motor for rotatingthe drive shaft and a shock absorbing element may be provided forcoupling the motor to the drive shaft. During steady state conditions,the shock absorbing element may transfer the full torque from the motorto the drive shaft. However, during abrupt increases in the differentialtorque between the motor and the drive shaft, the shock absorbingelement may absorb a portion of the increasing torque and, at the sametime, may maintain a mechanical coupling between the drive shaft and themotor preventing slippage.

In other embodiments, a rotational atherectomy system may include aclutch having a characteristic threshold torque, comprising a motorplate rotationally connected to the motor, a drive shaft platerotationally connected to the drive shaft, the motor plate and the driveshaft plate being parallel and coaxial, being disposed directlylongitudinally adjacent to each other, and being held proximate oneanother longitudinally with a space therebetween, and a biasing clutchconfigured to rotationally engage the motor plate and the drive shaftplate.

While multiple embodiments are disclosed, still other embodiments of thepresent disclosure will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. As will be realized, thevarious embodiments of the present disclosure are capable ofmodifications in various obvious aspects, all without departing from thespirit and scope of the present disclosure. Accordingly, the drawingsand detailed description are to be regarded as illustrative in natureand not restrictive.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the subject matter that is regarded as formingthe various embodiments of the present disclosure, it is believed thatthe invention will be better understood from the following descriptiontaken in conjunction with the accompanying Figures, in which:

FIG. 1 is a perspective view of a known rotational atherectomy device.

FIG. 2 is a block diagram of the motor, the drive shaft and the clutchthat mechanically couples them together.

FIG. 3 is a schematic drawing of the clutch of FIG. 2.

FIG. 4 is a plot of rotational speed of the drive shaft and torque atthe distal end of the drive shaft, for a typical procedure.

FIG. 5 is a plot of the torque transmitted to the proximal end of thedrive shaft, versus the torque of the motor.

FIG. 6 is a plot of torque at the distal end of the drive shaft versustime for a distal-end-stopping event, for a known gas turbine system.

FIG. 7 is a plot of torque at the distal end of the drive shaft versustime for a distal-end-stopping event, for the present motor-drivensystem with the clutch of FIG. 3.

FIG. 8A shows a biasing clutch according to some embodiments.

FIG. 8B shows a schematic diagram of one embodiment of the biasingclutch of FIG. 8A.

FIG. 8C shows a schematic diagram of another embodiment of the biasingclutch of FIG. 8A.

FIG. 8D shows a schematic diagram of another embodiment of the biasingclutch of FIG. 8A.

FIG. 9A shows a block diagram of a motor, a drive shaft, and a shockabsorbing element that mechanically couples them together.

FIG. 9B shows a plot of rotational speed of the drive shaft versus timefor a distal-end-stopping event, for a motor driven system with theshock absorbing element of FIG. 9A.

FIG. 10A shows a motor diagram of an atherectomy device having a shockabsorbing drive gear, according to some embodiments.

FIG. 10B shows a close-up view of the drive gear of FIG. 9B, accordingto some embodiments.

FIG. 11A shows a motor diagram of an atherectomy device having a shockabsorbing take-off element, according to some embodiments.

FIG. 11B shows a close-up view of the take-off element of FIG. 10A,according to some embodiments.

FIG. 12A shows a motor diagram of an atherectomy device having a shockabsorbing drive belt, according to some embodiments.

FIG. 12B shows a close-up view of the drive belt of FIG. 11A, accordingto some embodiments.

FIG. 13A shows a motor diagram of an atherectomy device having a shockabsorbing drive belt and idler system, according to some embodiments.

FIG. 13B shows a close-up view of the drive belt of FIG. 12A, accordingto some embodiments.

DETAILED DESCRIPTION OF THE INVENTION

An atherectomy device is disclosed, with a clutch between the motor andthe drive shaft. The clutch may include two plates that rely on frictionto transmit torque from one plate to the other. The clutch may have anattractive magnetic normal force that holds the plates together or, inanother embodiment, a biasing mechanism may hold the plates together.For relatively low torques, as is the case during normal use, a staticfrictional torque may hold the plates together, and the plates spintogether without slipping. For relatively high torques, as occurs whenthe distal end of the drive shaft encounters an obstacle and stopsabruptly, the high torque exceeds the maximum possible static frictionaltorque, and the plates slip. When slipping, the plates transmit akinetic frictional torque that is low enough to avoid damage to thepatient or to the atherectomy device. In some cases, the torque levelsassociated with a stoppage of the drive shaft distal end are chosen tomimic those of a known atherectomy device, in which a gas-driven turbineis clutchlessly attached to the drive shaft. In other embodiments,rather than a frictional force being used to transmit the torque, abiasing mechanism having variable torsional strength may be used totransfer the torque. For example, a spring may connect the clutch platesand may transfer the torque based on a torsional stiffness of thespring. When an obstruction is encountered, the variable torsionalstiffness may allow the spring to wind and may allow for delay in anexcessive torque at the distal end being applied. As such, the biasingmechanism in this embodiment may allow for a speed or currentinterrupter to cause the drive shaft to stop, for example.

The preceding paragraph is merely a summary, and should not be construedas limiting in any way. A more detailed description of the severalembodiments follows.

FIG. 1 is a schematic drawing of a typical rotational atherectomydevice. The device includes a handle portion 10, an elongated, flexibledrive shaft 20 having an eccentric enlarged abrading head 28, and anelongated catheter 13 extending distally from the handle portion 10. Thedrive shaft 20 is constructed from helically coiled wire as is known inthe art and the abrading head 28 is fixedly attached thereto. Thecatheter 13 has a lumen in which most of the length of the drive shaft20 is disposed, except for the enlarged abrading head 28 and a shortsection distal to the enlarged abrading head 28. The drive shaft 20 alsocontains an inner lumen, permitting the drive shaft 20 to be advancedand rotated over a guide wire 15. A fluid supply line 17 may be providedfor introducing a cooling and lubricating solution (typically saline oranother biocompatible fluid) into the catheter 13.

The handle 10 desirably contains a turbine (or similar rotational drivemechanism) for rotating the drive shaft 20 at high speeds. The handle 10typically may be connected to a power source, such as compressed airdelivered through a tube 16. A pair of fiber optic cables 25,alternatively a single fiber optic cable may be used, may also beprovided for monitoring the speed of rotation of the turbine and driveshaft 20. Details regarding such handles and associated instrumentationare well known in the industry, and are described, e.g., in U.S. Pat.No. 5,314,407, issued to Auth, and incorporated by reference herein inits entirety. The handle 10 also desirably includes a control knob 11for advancing and retracting the turbine and drive shaft 20 with respectto the catheter 13 and the body of the handle.

The abrasive element 28 in FIG. 1 is an eccentric solid crown, attachedto the drive shaft 20 near the distal end of the drive shaft 20. Theterm “eccentric” is used herein to denote that the center of mass of thecrown is laterally displaced away from the rotational axis of the driveshaft 20. As the drive shaft rotates rapidly, the displaced center ofmass of the crown causes the drive shaft to flex radially outward in thevicinity of the crown as it spins, so that the crown may abrade over alarger diameter than its own rest diameter. Eccentric solid crowns aredisclosed in detail in, for example, U.S. patent application Ser. No.11/761,128, filed on Jun. 11, 2007 to Thatcher et al. under the title,“Eccentric abrading head for high-speed rotational atherectomy devices”,published on Dec. 11, 2008 as U.S. Patent Application Publication No.US2008/0306498, and incorporated by reference herein in its entirety.

There is currently an effort to replace the gas-driven turbine of theknown atherectomy device with an electric motor. Such a motor hasdifferent mechanical characteristics than the turbine, such as anincreased rotational inertia. The present application is directed mainlyto a clutch that connects a motor to the drive shaft. Such a clutch canlimit the torque delivered by the motor, so that if the distal end ofthe drive shaft encounters an obstacle and suddenly stops rotating, theclutch will prevent a damaging amount of torque from being delivered tothe drive shaft. Aside from the motor, many or all of the other elementsof the known atherectomy device of FIG. 1 may be used with the presentdisclosed head design, including the catheter 13, the guide wire 15, thecontrol knob 11 on the handle 10, the helically coiled drive shaft 20and the eccentric solid crown 28.

FIG. 2 is a block diagram of the motor 30, the drive shaft 20 and theclutch 40 that mechanically couples them together. In this figure andthose that follow, the “motor” may be an electric motor, a gas-driventurbine, or any suitable device that generates a controllable amount ofrotation. During normal use, the clutch 40 is engaged, and the rotationproduced by the motor 30 is passed directly on to the drive shaft 20. Inthe event that the distal end of the drive shaft 20 becomes caught orencounters a blockage that suddenly stops its rotation, the clutchdisengages, so that the motor 30 does not continue to rotate theproximal end of the drive shaft. Such a continued rotation wouldexcessively wind up the drive shaft, and the torques associated withsuch a winding could potentially damage the blood vessel of the patientor the atherectomy device itself, which are both undesirable outcomes.

Additionally, the clutch may provide a convenient interface between thedrive shaft, which is typically a replaceable or disposable element, andthe motor, which is typically used repeatedly.

FIG. 3 is a schematic drawing of the clutch 40 of FIG. 2. The clutch 40includes two plates, 41 and 42, held together by an attractive magneticforce. The plates 41, 42 are attached to spindles that rotationallycouple them to the motor 30 and drive shaft 20, respectively.

During normal operation, including spin-up, constant rotational speeds,and spin-down, the difference in torque between the motor and theproximal end of the drive shaft is relatively small. For these smalltorque differences, the magnetic attractive force is sufficient to holdthe plates 41 and 42 together, and the proximal end of the drive shaftis spun along with the motor.

If the distal end of the drive shaft encounters an obstacle and issuddenly stopped from rotating, the torque difference between the motorand the proximal end of the drive shaft increases rapidly and eventuallyexceeds the static frictional torque that holds the plates together.When this happens, the plates slip rotationally with respect to eachother, and transmit a kinetic frictional torque from one to the other asthey slip. A detailed discussion of these frictional effects followsbelow.

Note that torque is the rotational analog of the quantity, force. Torqueproduces a change in angular momentum, much like linear force produces achange in linear momentum. Because the rotational inertia of the devicecomponents remains roughly constant throughout their operation, anon-zero torque therefore produces a change in rotational speed.

Note also that the two plates 41 and 42, which are held togethermagnetically, may provide a convenient interface for replacement. Forinstance, after a procedure has been performed, the drive shaft andassociated mechanical parts may be removed by detaching themagnetically-attracted plates 41 and 42. Plate 42 is disposed of, alongwith the drive shaft, while plate 41 remains with the motor unit and maybe used repeatedly.

FIG. 4 is a plot of rotational speed of the drive shaft and torque atthe distal end of the drive shaft, for a typical procedure. Initially,the drive shaft is at rest and there are no net torques present. Duringthe “spin-up” phase, the motor applies a non-zero torque to the proximalend of the drive shaft, and the rotational speed of the drive shaftincreases. Once a desired rotational speed is reached, the torque of themotor is reduced to keep the drive shaft at a constant rotational speed.Note that the actual torque applied by the motor to the proximal end ofthe drive shaft may be small but non-zero, in order to overcome theeffects of friction between the proximal and distal ends of the driveshaft. The plot shows the torque at the distal end of the drive shaft,which is truly zero when the distal end of the drive shaft rotates at aconstant rotational speed. During the “spin-down” phase, the motorapplies a non-zero torque in the opposite direction to reduce therotational speed of the drive shaft to zero.

The typical torque levels shown in FIG. 4, which commonly occur duringuse, are usually below a threshold at which the plates 41, 42 in theclutch 40 begin to slip. During normal use, the clutch remains engaged,and the static frictional force between the plates holds the platestogether. It is desired that the plates slip, and the clutch disengages,only during an atypical event, such as when the distal end of the driveshaft becomes stuck and stops rotating. However, it is possible that theplates may slip during spin-up and/or spin-down, due to the spin-upand/or spin-down torques exceeding the threshold.

At this point, it is instructive to review the physics of frictionalforces, in order to better understand when the clutch plates holdtogether, and when they slip.

Consider for a moment two linear plates, rather than two rotating platesas in the true clutch of FIG. 3. The linear plates are held together bya normal force that can be generated magnetically, as is the case of theclutch of FIG. 3, or can be generated externally. For relatively smallforces parallel to the contact surfaces, the plates hold together. Inother words, if one pushes gently on one plate, parallel to the contactsurfaces, the other plate holds with it and there is no slippage. Forrelatively large forces parallel to the contact surface, such as astrike with a hammer, the plates no longer hold together, and slip pasteach other along the contact surface.

The threshold at which slippage begins to occur is given by the productof the normal force (i.e., the force holding the plates together,generated magnetically or otherwise) and a coefficient of staticfriction. The coefficient of static friction is a dimensionless quantitythat is typically less than one. For forces less than this threshold,the plates hold together. For forces greater than this threshold, theplates slip.

As an example, consider the interface between a rubber tire and a roadsurface. For a small normal force, as is the case when the tire issimply resting on the road under the effects of its own gravitationalweight, it is easy to drag the tire along the road surface. For a largenormal force, as is the case when the tire supports the weight of a car,it is quite difficult to overcome the frictional forces that keep thetire in contact with the road. In practice, skidding only occurs forlarge forces, such as slamming on the brakes during driving conditions.

From this example, we may state a first general principle for ourclutch: the normal force (i.e., the magnetically-generated force thatattracts the plates to each other) determines the threshold at whichslipping between the plates begins to occur.

Such a normal force is controllable at the design phase of the clutch,and may be controlled by the lateral distribution of magnetic materialsin the plates, as well as the longitudinal distribution of thosematerials. For instance, the normal force decreases as the longitudinalspacing between the magnetic particles increases; such spacing can beachieved in many ways, such as by coating the magnetic particles with anon-magnetic layer.

Returning to the example of the two linear plates, consider now the casewhen the plates are already slipping past each other. There is aresisting force generated at the contact surfaces, which would slow downand eventually stop the slipping motion, if no other forces were atwork. Likewise, if one were to push of the sliding plates parallel tothe surfaces with a force equal to the resisting force, there would beno net forces on the plates and the plates would maintain a constantvelocity between them.

The resisting force is equal to the product of the normal force and acoefficient of kinetic friction. The coefficient of kinetic friction isalso a dimensionless quantity, also typically less than one.Furthermore, the coefficient of kinetic friction is usually less thanthe coefficient of static friction; this is the reason behind theeffectiveness of automotive anti-lock brakes, which can impart a greaterstopping force if there is no skidding involved.

Importantly, the resisting force does not depend on the velocity betweenthe plates; as long as there is slipping between the plates, theresisting force depends only on the normal force between the plates.

We may state a second general principle for our clutch: the normal force(i.e., the magnetically-generated force that attracts the plates to eachother) determines the torque transmitted from one plate to the otherwhen the plates are slipping.

These two general principles are summarized in FIG. 5, which is a plotof the torque transmitted to the proximal end of the drive shaft(vertical axis), versus the torque of the motor (horizontal axis).

If there were no clutch present, and the drive shaft were rotationallyattached directly to the motor, the “no slipping” curve in FIG. 5 wouldincrease from the origin to the upper right edge of the plot in a 1:1relationship. In other words, for a clutchless attachment, all of themotor torque is always transmitted to the drive shaft.

At relatively low torques, at which the clutch is engaged and the platesare in contact and do not slip with respect to each other, the 1:1relationship is seen. In normal use, such as during the spin-up andspin-down portions of the atherectomy cycle, the torques produces by themotor are considered relatively low, so that the clutch remains engagedthroughout the procedure. On the plot in FIG. 5, this corresponds to the45-degree branch extending to the right and upward from the origin(labeled “no slipping”).

At some particular torque threshold, we want slipping to start, in orderto prevent damage to the patient and to the device itself. Thisthreshold occurs at the top-right point of the “no slipping” curve, andis proportional to the normal force. Slipping occurs when the torque ofthe motor equals or exceeds this threshold value.

When there is slipping between the plates in the clutch, the torque thatis transmitted to the drive shaft cannot exceed a particular “slipping”value, regardless of how large the actual torque of the motor is. Thislimits the maximum torque that can be transmitted to the drive shaft,which also prevents damage to the patient and to the device itself. This“slipping” torque value is also proportional to the normal force, andmay be referred to herein as a “residual” torque.

Note that because the kinetic coefficient of friction is generally lessthan the static coefficient of friction, the two curves intersect asshown in FIG. 5, with the “no slipping” portion extending upward at tothe right, beyond the intersection point.

In general, the curves in FIG. 5 are scalable in proportion to thenormal force. If the normal force is doubled, for example, the “noslipping” curve extends twice as far to the top-right, and the“slipping” torque value is doubled. The normal force is controllableduring the design phase of the clutch, through the choice of magneticmaterials in the plates and the lateral and longitudinal placement ofthose materials.

The curves of FIG. 5 are plotted as torque versus torque. In order tosee how these torques evolve in time when the distal end of the driveshaft is abruptly stopped, two examples are presented in FIGS. 6 and 7.FIG. 6 pertains to a known system, in which the drive shaft is connectedto a gas turbine, and does not use a clutch. The rotational inertia ofthe gas turbine is small enough so that the associated torques do notcause any damage to the patient or to the device. FIG. 7 pertains to asystem that uses a higher-rotational-inertia motor, such as an electricmotor, which uses the clutch to prevent damage. In particular, the peakand steady-state torque values in FIG. 7 are chosen to mimic those inFIG. 6, which have been determined to be acceptable in practice.

We first turn to FIG. 6, which is a plot of torque at the distal end ofthe drive shaft versus time for a distal-end-stopping event, for a knowngas turbine system. The known gas turbine system does not have a clutch.

Initially, both the motor and drive shaft are spinning together. Therotation is assumed to be at a constant rotational speed, so there is nonet torque on the distal end of the drive shaft.

Next, the distal end of the drive shaft is stopped abruptly, as wouldhappen if it got stuck or encountered an obstacle in the blood vessel.

Following the abrupt stop, the drive shaft begins to wind up, orrotationally compress. Such a compression is analogous to a linearspring; the more it is compressed, the harder it becomes to impartadditional compression. In this phase, the draft shaft essentially“pushes back” rotationally on the motor, and the motor slows down.

There comes a point when all the rotational energy has gone intorotationally compressing the spring, and the spring and motor arestopped at the spring's maximum compression point. At this point, thedistal end of the drive shaft experiences its maximum torque.

Following the maximum compression, the drive shaft “springs back” andunwinds a bit. During this unwinding, the motor and the proximal end ofthe drive shaft run in reverse. In practice, there may be some “ringing”to this curve, as the energy in the system oscillates between kinetic(movement) and potential (rotational compression of the drive shaft).Much of the “ringing” is damped due to friction, and the oscillationsbecome increasingly small as system settles to a stationary steadystate. The “ringing” is omitted from FIG. 6.

At this steady state, the motor is stopped but is still applying atorque. The drive shaft is also stationary, but is stationary in arotationally compressed position due to the motor torque.

The entire horizontal axis of FIG. 6 may last on the order ofmilliseconds. The known gas turbine may have a control system thatdetects when its rotational speed falls below a threshold value or fallsto zero and subsequently shuts off the motor. Such a control system mayrequire a particular length of time to react, typically on the order ofseveral seconds. These control systems cannot react directly to portionsof the curve of FIG. 6, though, because the spike and settling tosteady-state typically occurs much more rapidly than the control systemcan react.

There are two torque values to note on the curve of FIG. 6. The firstvalue is the peak value, which occurs when the drive shaft is mosttightly wound and the motor is stopped. The second value is thesteady-state value. Both of these torque values have been deemed safefor use in the known, gas turbine-driven atherectomy system. As aresult, the clutch 40 may be designed to mimic one or both of these safetorque values.

FIG. 7 is a plot of torque at the distal end of the drive shaft versustime for a distal-end-stopping event, for the present motor-drivensystem with the clutch of FIG. 3. One difference between FIGS. 6 and 7is that for the present clutch design, the motor continues to turnthroughout the clutch disengagement; for the known gas turbine of FIG.6, the turbine stops along with the drive shaft. Such a stopping of thepresent motor is not feasible because of the relatively large rotationalinertia of the motor.

Initially, both the motor and drive shaft are spinning together. Therotation is assumed to be at a constant rotational speed, so there is nonet torque on the distal end of the drive shaft. The clutch is engaged,and there is no slipping between the plates of the clutch.

Next, the distal end of the drive shaft is stopped abruptly. As withFIG. 6, the spiked torque associated with stopping the distal end isomitted from FIG. 7.

Following the abrupt stop, the drive shaft begins to wind up, orrotationally compress. In this phase, the draft shaft essentially“pushes back” rotationally on the motor, and the motor may slow down. Inpractice, this slowing down of the motor may be very slight, because therotational inertia of the motor may be quite large, especially comparedwith that of the gas turbine discussed above.

Eventually, as the distal end of the drive shaft remains fixed and theproximal end of the drive shaft continues to wind, there will reach apoint when the torque difference between the motor and the proximal endof the drive shaft equals the threshold torque, beyond which the clutchplates start to slip. This threshold point corresponds to the peak ofthe curve in FIG. 7.

One may trace the progress thus far in FIG. 5. Initially, while themotor and drive shaft are spinning together, the system as at theorigin. After the distal end is stopped, the system rises upward and tothe right along the “no slipping” curve. The threshold point, which isthe peak of the curve in FIG. 7, is at the top-right-most edge of the“no slipping” curve in FIG. 5.

Once the plates begin to slip, the clutch becomes disengaged. The motorcontinues to rotate, along with plate 41 of the clutch 40. The otherplate 42, however, rotates more slowly than the plate 41, and eventuallystops and unwinds, along with the proximal end of the drive shaft. Onceany ringing effects have died off and steady state is reached, the driveshaft is stationary and slightly wound, the proximal end of the driveshaft is stationary, the plate 42 is stationary, the plate 41 remainsrotating along with the motor, and rotating plate 42 transmits enoughtorque to stationary plate 41 to keep the drive shaft slightly wound.

Essentially, the torque transmitted by the clutch 40 in its slippingmode is analogous to the torque of the gas turbine of FIG. 6 when thegas turbine is stationary. In fact, during the design phase of theclutch 40, the attractive magnetic normal force between the plates canbe set so that the steady-state torque of FIG. 7 matches that of FIG. 6,since the steady-state torque of the gas turbine has been deemed safefor use. Alternatively, the attractive magnetic normal force between theplates can be set so that the peak torque, i.e., the threshold torquevalue at which the plates begin to slip (the peak in FIG. 7), matchesthat of FIG. 6. As a further alternative, both the peak and steady-statetorque values can be met by texturing one or both surfaces of theclutch, adjusting the diameter of the contact surfaces, and/or adjustingthe materials on the opposing faces in the clutch.

Although the plates 41 and 42 are drawn in FIG. 3 as being coaxial andcircular, other suitable shapes and orientations may be used. One orboth surfaces may optionally be textured, which can adjust the surfacearea in contact and may affect the frictional performance of theinterface. In addition, the plates 41 and 42 may optionally be curved,and may have mating curvatures that fit together. For instance, oneplate may be convex with a particular radius of curvature, and the otherplate may be concave with the same radius of curvature.

Referring now to FIG. 8A, an additional embodiment of a clutch 140 isshown. In this embodiment, a clutch 140 is formed by a boundary element141 formed by a pair of loft flanges secured to one another androtationally coupled (e.g., keyed) to the motor. The clutch may alsoinclude a boundary element 142 formed by another loft flange secured toa tube 139, such as a hypotube that is used to rotate the drive shaft.As shown, a biasing mechanism 144 may be arranged between the boundaryelements 141, 142 to transfer the torque from the motor to the driveshaft via the boundary elements 141, 142. It is to be appreciated that,while the boundary elements 141, 142 have been described as loftflanges, these elements may take other forms such as disc-shaped plates,square plates, hollow or solid cylindrical cylinders, or other shapedboundary elements 141, 142 may be provided.

Referring now to FIG. 8B, a schematic diagram of a first biasingmechanism 144A is shown. In this embodiment, the function of the clutch140 may be very similar to that of the magnetic clutch 40 previouslydescribed. That is, a spring 148A or other biasing mechanism 144A mayextend from one of the faces of one of the loft flanges 142A and a plate146A may be provided on one end of the spring 148A opposite the flange142A that the spring 148A is attached to. The plate 146A mayfrictionally engage the faces of the opposing loft flange 141A. Thespring 148A may have a relaxed length longer than the distance betweenthe loft flanges 141A, 142A and, as such, the spring 148A may becompressed to fit within the loft flanges 141A, 142A thereby creating alongitudinal normal force that presses the plate 146A against the loftflange 141A. Like the magnetic clutch described, the friction betweenthe plate 146A and the loft flange 141A may be sufficient to supporttransfer of a threshold torque between the plates, but when thethreshold torque is exceeded (e.g., when the drive shaft hits anobstruction) the plate 146A and the loft flange 141A may slip therebyreducing the torque transfer to a torque based on kinetic friction inlieu of static friction. It is noted, however, that in addition to theslippage of the plate 146A and the loft flange 141A the use of a spring148A to bias the plate may provide some amount of additional torsionalplay in the system. As such, when the drive shaft hits an obstruction,in some embodiments, the torsional stiffness of the spring 148A mayresult in some relative rotation of the hypotube and motor prior to theslippage of the frictional surface. It is to be appreciated that whilethe spring 148A is shown as being attached to the loft flange 142A onthe hypotube 139A and the plate 146A is shown to frictionally engage theloft flange 141A coupled to the motor, the reverse may also be provided.

Referring now to FIG. 8C, a schematic diagram of a second biasingmechanism 144B is shown. In this embodiment, the function of the clutch140 may remain similar to that of the magnetic clutch. In thisembodiment, rather than placing the spring 148B and plate 146B betweenthe loft flanges 141B, 142B, the plate 146B may be positioned on thetube 139B and secured to prevent longitudinal movement of the plate 146Brelative to the tube 139B. The loft flange 142B on the tube 139B may belongitudinally slidable, but rotationally coupled to the hypotube 139Bthrough a key or square drive fitting or other relative rotationresisting connection. Like the embodiment of FIG. 8B, a spring 148B maybe provided that has a relaxed length longer than the space available inthe system. As such, the spring 148B may be compressed between the plate146B and a loft flange on the hypotube 139B thereby biasing the loftflange 142B on the tube 139B against the loft flange 141B coupled to themotor and creating a friction based torque transferring connection. Thisembodiment may also be reversed by placing the plate 146B and spring148B on the motor side of the clutch, for example. Like the embodimentof FIG. 8B a threshold torque may be supported, but may be overcome ifan obstruction is encountered. However, unlike the embodiment of FIG.8B, since the spring 148B is not carrying torque in this embodiment,play provided in FIG. 8B may not be available. However, it is appreciatethat the plate 146B and spring 148B may be rotationally coupled to thetube 139B and the loft flange 142B on the tube 139B may be positioned onthe tube 139B to allow for both rotational and longitudinal movementsuch that the spring 138B transfers the torque to the loft flange 142B.In this latter situation the play from the spring 148B may be provided.

Referring now to FIG. 8D, a schematic diagram of yet another biasingmechanism 144C is shown. In this embodiment, the two boundary elements141C, 142C of the clutch may be directly secured to one another with abiasing mechanism 144C such as a spring 148C, for example. The spring148C may have a relaxed length equal to, larger, or smaller than thespace provided between the loft flanges 141C, 142C. When in place, thespring 144C may have a torsional resistance that may change based on howtightly wound the spring 148C is. As such, upon actuation of the driveshaft, the spring 148C may wind up tighter until equilibrium is foundbetween the torque required to rotate the drive shaft and the torsionalresistance supplied by the spring 148C. In this embodiment, when anobstruction is encountered, the added torque applied to the spring 148Cmay cause the spring 148C to further wind allowing the loft flanges141C, 142C of the clutch to rotate relative to one another and, thus,not fully transfer the torque from the motor. In this embodiment, sinceno slippage is provided by the clutch, the system may be furtherequipped with a speed or current limiting switch for switching off themotor when an obstruction is encountered. However, at initial impactbetween the distal end of the drive shaft and the obstruction, theclutch may allow for some play in the system and avoid relatively hightorques from being realized. Systems for releasing the torque providedby the motor based on torque, current, voltage, speed reduction and thelike are discussed in U.S. patent application Ser. No. 12/713,558, thecontents of which are hereby incorporated by reference herein in theirentireties.

Referring now to FIG. 9A, a block diagram and torque graph are shownthat may reflect the embodiment of FIG. 8D. That is, in the embodimentof FIG. 8D, for example, a slipping type clutch is not provided and,instead, a shock absorbing spring 144C is provided to elastically couplethe motor 30 to the drive shaft 20. The block diagram of FIG. 9A showsthis in a block form indicating that as the motor 30 spins a firstdirection, the shock absorbing element 240 may directly transfer thetorque to the drive shaft 20. That is, at initial startup, for example,the shock absorbing element 240 may elastically stretch or compress ordeform in shear by an initial amount until the elasticity of the shockabsorber finds equilibrium with the torsional friction/resistance beingencountered by the drive shaft 20. Beyond that point, aside fromsituations where the torsional resistance witnessed by the drive shaft20 varies, the motor 30, the shock absorber 240, and the drive shaft 20may rotate at a state of equilibrium where the rotational speeds differby any gearing changes, but otherwise remain consistent.

Referring now to FIG. 9B, a time versus distal end torque diagram may bereviewed. As shown, at the left side of the graph, the drive shaft 20may be spinning and the torque at the distal end of the drive shaft 20may be negligible. That is, while some resistance to tip spinning may bepresent, for our purposes, we may assume that the steady state conditionprovides a tip resistance that is approximately zero.

When the tip of the drive shaft 20 comes to an abrupt stop the torqueapplied to the distal end of the drive shaft 20 may begin to increase.That is, assuming that an interrupter is not immediately activated tointerrupt the motor rotation, the motor 30 may continue to rotate whenthe distal end of the drive shaft 20 stops. This additional torquecreated due to the non-rotating distal tip and the rotating motor 30 maycause the torque at the distal end of the drive shaft to increase. Thatis, the rotating motor 30 may continue to act on the shock absorbingelement 240, which, although it may give slightly, will also transfersome of the additional torque through to the drive shaft 20. As themotor 30 continues to rotate, additional torque may be applied to theshock absorbing element 240, which may absorb some of the torque, butmay also transfer some additional torque to the drive shaft 20. Theresult is that the shock absorbed torque at the distal end of the driveshaft 20 may be lower and take longer to reach than the inertial torqueshown in dashed lines in FIG. 9B. That is, in the non-shock absorbedcondition, the motor 30 may rotate until the drive shaft 20 reaches itsfully wound unresilient condition causing the motor 30 to come to a stopin a short amount of time and causing the full torque of the motor inaddition to its loss of momentum to be transferred through the driveshaft 20. In contrast, the shock absorbing embodiments (see FIGS. 8D,10-13) provide more time for the motor 30 to come to a stop because theshock absorbers 240 allow the motor 30 to rotate through a larger amountof rotation before coming to a stop. Since the torque due to themomentum of the motor 30 is dependent on how abruptly the motor 30stops, this shock absorbing effect reduces the peak torque. As such, ifthe motor is uninterrupted, the final torque at the distal tip may be ashigh as the torque applied by the motor 30, but the torque at the peakmay be only slightly higher than the applied torque.

Referring now to FIG. 10A, a first embodiment of a shock absorbingsystem may be shown. As shown, the motor 30 may include a rotating drive242 that is rotationally coupled to a drive gear 244. The drive gear 244may be rotationally engaged with a take-off gear 246 that may be keyedor otherwise coupled to the drive shaft 20 such that rotation of thetake-off gear 246 imparts rotation on the drive shaft 20 of theatherectomy device. Accordingly, the motor 30 may be directly geared tothe drive shaft 20 and a slip clutch may be omitted. However, as shown,the drive gear 244 may be a shock absorbing drive gear 244 such thatresistance to rotation at the drive shaft 20 may be absorbed slightly bythe drive gear 244 before increasing the torque in the drive shaft 20due to motor rotation.

As shown in more detail in FIG. 10B, the drive gear 244 may include aninternal hub 248 for securing to the rotating drive 242 of the motor 30.The gear 244 may also include a peripheral ring 250 having a pluralityof teeth 252 selected together with the tooth count on the take-off gear246 to provide a suitable gear ratio and allowing for an efficient motorspeed relative to drive shaft speed. The hub 248 of the drive gear 244may be secured to the peripheral ring 250 of the drive gear 244 with aresilient or shock absorbing system. That is, for example, as shown, theshock absorbing system may include a plurality of radially extendingelements 254 extending generally radially outward from the hub 248 to aninner surface of the peripheral ring 250. In the present embodiment, theradially extending elements 254 may be substantially S-shaped and theremay be four of these shapes. Still other shapes and numbers of radiallyextending elements 254 may be provided. For example, a series of spokes,struts, or a substantially flat diaphragm may be provided. Still otherresilient shock absorbing elements may be provided for resilientlyconnecting the hub 248 to the peripheral ring 250.

In some embodiments, the drive 244 gear may be a molded product that maybe tuned by adjusting and/or changing the molded geometry. In otherembodiments, the shock absorbing portion of the gear 244 may be aseparate component and tuning or adjusting the resiliency of the systemmay involve removing and replacing the shock absorbing portion with oneof higher or lower resiliency.

The S-shaped portion of the radially extending elements 254 may have abase 256 having an axis extending substantially directly radiallyoutward from the hub 248. The S-shaped portion may include a bentportion 258 turning approximately 90 degrees from the base 256 and thenan approximately 180 degree U-turn portion 260 may be provided. Acentral crossing member 202 may return across the shape slightly pastthe base 256 to another U-turn portion 264. An additional 90 degreeportion 266 may be provided and an opposing base 268 on the insidesurface of the peripheral ring 250 may be provided that is substantiallyradially aligned with the corresponding base 256 on the hub 248. It isto be appreciated that while a particular shape for the radiallyextending portion 254 has been described, still other geometries for theradially extending portion 254 may be provided.

As can be appreciated, the resilient radially extending portions 254 ofthe drive 244 gear may deflect under load allowing the hub 248 to rotaterelative to the peripheral ring 250 thereby increasing the rotationallowed for the motor 30 in a stoppage condition. This increasedrotation may extend the time and distance over which the motor 30 isdrawn to a stop thereby reducing the amount of inertial torquetransmitted to the drive shaft 20 due to the stoppage.

Referring now to FIG. 11A, another embodiment of a shock absorbingsystem is shown. In this embodiment, similar to that of FIG. 10A, amotor 30 includes a rotating drive 242 coupled to a drive gear 270. Thedrive gear is engaged with a take-off gear 272. However, unlike theembodiment of FIG. 10A, the present take-off gear 242 might not be keyedto the drive shaft 20, but may, instead be coupled to the drive shaft 20with a resilient or shock absorbing element 274. As such, resistance torotation experienced by the drive shaft 20 may be absorbed slightly bythe shock absorbing element 274 when the rotation of the motor 30attempts to increase the torque in the drive shaft 20.

As shown in more detail in FIG. 11B, the take-off gear 272 may bearranged concentrically on the drive shaft 20, for example, but may befree to rotate relative to the drive shaft 20. However, one face of thetake-off gear 272 may be engaged with one end of a resilient member 274such as a coil, spring, or other biasing mechanism. The transitionbetween the take-off gear 272 and the resilient member 272 may include awasher plate, for example. The resilient member 274 may be positionaround the drive shaft 20 and may extend away from the take-off gear 272to a free end. At the free end of the resilient member opposite thetake-off gear 272 a coupling element such as another washer plate maysecure the drive shaft to this opposite end. The two ends of theresilient member 274 may be welded, keyed, pinned, or threaded throughfor example, or otherwise fixed to the take-off gear 272 and the driveshaft 20. As such, rotation of the take-off gear 272 due to the drivegear 270 may cause rotation of the resilient member 274 thereby causingrotation of the drive shaft 20. However, where the drive shaft 20experiences resistance to rotation, the resilient member 274 may absorbsome of the torque of the motor 30 before transferring such torque tothe drive shaft 20. As such, the impact of the inertial force on thedrive shaft 20 due to the rotating motor 30 may be reduced. It is to beappreciated that while a resilient member 274 in this embodiment hasbeen described as a coil or spring, the resilient member 274 may includea resilient cylindrical bushing made of a resilient material, a meshmaterial or another material allowing for the torque transfer betweenthe take-off gear 272 and the drive shaft 20 to be controlled.

Referring now to FIG. 12A, yet another shock absorbing device may beprovided. In this embodiment, unlike the embodiments of FIGS. 10A and11A, the present embodiment may be a belt-drive system. As such, thesystem may include a motor 30 having a rotating drive 242. The rotatingdrive 242 may have a drive pulley 276 arranged thereon and keyed theretoto or otherwise coupled to transfer rotational motion between therotating drive 242 and the pulley 276. The system may also include atake-off pulley 278 arranged generally in plane with the drive pulley276 and rotationally coupled to the drive shaft 20. In this embodiment,the drive pulley 276 may be rotationally coupled to the take-off pulley278 with a resilient belt 280.

In more detail in FIG. 12B, the belt 280 may be arranged to extendaround the drive pulley 276 and the take-off pulley 278. The belt 280may be arranged relatively tightly on the two pulleys 276, 278 therebytransferring torques from the motor 30 to the drive shaft 20 based onthe friction of the belt 280 on the surface of each pulley. It is to beappreciated that when the drive pulley 276 is rotating, for example,clockwise in FIG. 12B, the left side of the belt 280 may be in a higherlevel of tension than the right side stemming from any resistance torotation that may be present in the drive shaft 20 or other downstreamportion of the system. When the drive shaft 20 encounters resistance torotation, the resilient belt 280 may stretch on the higher tension sideof the system and tension on the other side of the system may beslightly relieved due to the increase in differential torque. As such,the belt 280 may be effective to absorb some of the torque from themotor 30 when the drive shaft 20 encounters resistance to rotation. Itis to be appreciated that several different belt profiles orcross-sections may be provided. In some embodiments, a round belt, atriangular belt, a rectangular belt, a trapezoidal belt, or other shapedcross-section may be provided. In some embodiments, the cross-sectionalshape of the belt 280 may be particularly selected due to its ability toabsorb differential toque by deforming based on internal shear forces.

Referring now to FIG. 13A, yet another embodiment of a shock absorbingdevice may be provided. In this embodiment, like the embodiment of FIG.12A, the system may be a belt-driven system. However, it will beappreciated that this particular system could be chain driven orotherwise driven with a more rigid-type belt. In this embodiment, therotating drive 242 of the motor 30 may include a drive pulley 276 thatis rotationally coupled to a take-off pulley 278 on the drive shaft 20with a belt 280, for example. However, an additional idler pulley may beprovided and, as shown, two idler pulleys 282A, 282B may be provided.Like the system of FIG. 12A/12B, the present system may rely on the beltto absorb some of the differential torque, however, the idler pulleys282A, 282B may also be resilient allowing for more control over thelevel of shock absorption in the system.

Referring to the more detailed view of FIG. 13B, the several pulleys anda belt are shown. As shown, the idler pulleys 272A, 272B may be arrangedalong and generally close to the tangent line connecting the outer beltsurface of the broader diameter drive pulley 276 to the outer beltsurface of the smaller take-off pulley 278. The belt 280 may be routedaround respective inside surfaces of the idler pulleys 282A, 282Bcreating a substantially inverted tear shaped belt route. The idlerpulleys 282A, 282B may be positioned on resiliently secured centershafts 284A, 284B such that increased tension on one side of the systemmay draw one of the idler pulleys 282A out of position while a decreasein tension on the opposing side may cause the respective idler pulley282B to take up any slack occurring in the belt 280. For example, wherethe belt in FIG. 13B is rotating clockwise about the drive pulley 276 aparticular amount of tension may be present in the left portion of thebelt 280, while a slightly lesser amount of tension may be present inthe right portion of the belt 280. When the drive shaft 20 encounters anobstruction, the resistance to rotation of the drive shaft 20 mayincrease causing the tension in the left portion of the belt 280 toincrease drawing the left idler pulley 282A outward. Similarly, thetension in the right portion of the belt 280 may decrease allowing theright pulley 282B to move inward to take-up any slack. Since the amountof increased tension on the left may be similar to the amount ofdecreased tension on the right, the two idler pulleys 282A, 282B, insome embodiments, may be arranged on a common frame such that the rightpulley moves inward by an amount equal to or similar to the amount thatthe left pulley moves outward.

The present shock absorbing systems may be advantageous for absorbingrelatively high torsional loading without damaging the medical devicedrive shaft. The device may provide a means for absorbing the loadsallowing the shaft and crown to stop rotating without stopping the wholedrive system stopping. In the absence of such a system, the drive shaftmay otherwise be the shock absorbing element and may need to beconsiderably stronger than those using the shock absorbing technology.With the shock absorbing technology, the drive shaft may be designed toperform the function of rotating the sanding member or crown, withoutthe added strength due to shock loading. As described, the shockabsorbing member may be arranged on the motor side (i.e., like FIGS.10A/10B), on the drive side of the drive line (i.e., like FIGS.11A/11B), or the member may be placed between the drive side and thedriven side of the drive line (i.e., like FIGS. 12A/12B and 13A/13B).

The description of the invention and its applications as set forthherein is illustrative and is not intended to limit the scope of theinvention. Variations and modifications of the embodiments disclosedherein are possible, and practical alternatives to and equivalents ofthe various elements of the embodiments would be understood to those ofordinary skill in the art upon study of this patent document. These andother variations and modifications of the embodiments disclosed hereinmay be made without departing from the scope and spirit of theinvention.

What is claimed is:
 1. A rotational atherectomy system comprising: amotor; a drive shaft in operative connection with the motor, the motorcapable of rotating the drive shaft; and a shock absorbing element inoperative connection with the motor and the drive shaft and comprising aresilient element capable of elastic deformation.
 2. The rotationalatherectomy system of claim 1, wherein the shock absorbing elementcomprises: a drive gear operatively connected with the motor andcomprising: a drive gear hub; a peripheral ring having a plurality ofteeth; and a plurality of resilient radially extending elementsoperatively connected to the drive gear hub and extending radially tothe peripheral ring and capable of deflection under load to allow thedrive gear hub to rotate relative to the peripheral ring; and a take-offgear in operative communication with the drive gear and with the driveshaft.
 3. The rotational atherectomy system of claim 2, the plurality ofresilient radially extending elements comprising: a base connected withthe drive gear hub and having an axis extending substantially directlyradially outward from the drive gear hub; an opposing base connected tothe peripheral ring and substantially radially aligned with the base;and a substantially S-shaped portion connected between the base and theopposing base.
 4. The rotational atherectomy system of claim 2, theplurality of resilient radially extending elements comprising a seriesof spokes or struts connected with the base and with the opposing base.5. The rotational atherectomy system of claim 2, the plurality ofresilient radially extending elements comprising a substantially flatdiaphragm connected with the base and with the opposing base.
 6. Therotational atherectomy system of claim 2, further comprising thetake-off gear being keyed to the drive shaft.
 7. The rotationalatherectomy system of claim 2, further comprising the take-off gearbeing not keyed to the drive shaft and wherein the shock absorbingelement further comprises: a resilient member operatively engaged withthe take-off gear and operatively engaged with the drive shaft.
 8. Therotational atherectomy system of claim 7, the resilient membercomprising opposing ends and wherein a first end is operativelyconnected with the take-off gear and the opposing end is operativelyconnected with the drive shaft.
 9. The rotational atherectomy system ofclaim 7, the resilient member comprising a coil or spring.
 10. Therotational atherectomy system of claim 7, the resilient membercomprising a resilient cylindrical bushing.
 11. The rotationalatherectomy system of claim 1, wherein the shock absorbing elementcomprises: a drive pulley operatively connected with the motor; atake-off pulley in operative communication with the drive pulley andwith the drive shaft; and a resilient, stretchable belt in operativeengagement with the drive pulley and the take-off pulley.
 12. Therotational atherectomy system of claim 1, wherein the shock absorbingelement comprises: a drive pulley operatively connected with the motor;a take-off pulley in operative communication with the drive pulley andwith the drive shaft; a belt or chain in operative engagement with thedrive pulley and the take-off pulley; and at least one idler pulleydisposed between the drive pulley and take-off pulley, the at least oneidler pulley having an inner surface, the inner surface in operativeengagement with the non-resilient belt or chain, the at least one idlerpulley positioned on a resiliently secured shaft and arranged to bedrawn outwardly out of position with increased belt or chain tension.13. The rotational atherectomy system of claim 12, further comprisingthe drive pulley having an outer surface and two idler pulleys, eachidler pulley arranged substantially along a tangent line connected thedrive pulley's outer surface and the inner surface of the idler pulley,wherein the shape of the non-resilient belt or chain comprises aninverted tear shape.
 14. A method for reducing torque experienced at thedistal end of a rotational atherectomy drive shaft during blockage ofthe drive shaft, comprising: providing a motor; providing a drive shaftin operative communication with the motor and capable of being rotatedat high rotational speeds by the motor; and providing a shock absorbingelement in operative connection with the motor and the drive shaft andcomprising a resilient element capable of elastic deformation.
 15. Themethod of claim 14, further comprising providing a clutch in operativeengagement with the shock absorbing element.